Engineering Projects Senior Manager (C&Q)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen our shared mission, to serve patients, drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing & delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
What you will do
Lets change the world. In this vital role you will independently manage and oversee complex Commissioning and Qualification activities within capital projects involving the planning, design, construction, and execution of manufacturing process equipment, facilities and utilities. You will lead a commissioning team leveraged from within the company and external partners, for complex, technical projects, to coordinate the implementation of highly innovative and ingenious solutions to support Amgens business needs.
Amgen recently announced plans to build a new 270,000 sf / $400M greenfield packaging facility in New Albany, OH. The Project has been funded and enabling works are in progress with construction to start in the fall of 2021 with a target completion date in 2024.
Amgen is searching for an experienced Commissioning and Qualification (C&Q) manager (reporting to the Project Director) to lead the C&Q scope of this new site. The C&Q lead will be responsible for delivering all aspects of the C&Q Program on site, including facilities, utilities, warehouse (ASRS & AGVs), and process (packaging & Assembly lines) equipment. This includes front end planning, estimating, program setup, implementation, execution, and closure. The Senior Manager is responsible for ensuring commissioning and qualification delivery meets the program requirements and is cost effective for Amgen.
This position will also drive operational improvement strategies, shares and incorporates best practices and lessons learned, and partners with key stakeholders. The role will require local presence, therefore relocation near the job site (New Albany, Ohio) is essential.
As a permanent staff member there will be significant opportunities beyond this project for further career development through potential future site expansions, facility management opportunities once facility is operational as well as numerous opportunities across the Amgen network.
Other Responsibilities include:
Assists GSS on scope of work definition of external contractors and reviews contractual documentation.
Responsible for staffing projects with suitably qualified resources and providing guidance and oversight on program implementation.
Prepares and keeps up-to-date the pre-commissioning and commissioning execution plans (including the schedule and the mobilization of personnel and equipment).
Manages day to day Commissioning and Qualification activities including planning, staffing, schedule development and overall tracking and reporting of status and issues
Directly manages execution of commissioning and qualification aspects of projects including C&Q document preparation, execution, and daily coordination
Supervises the preparation of the pre-commissioning and commissioning procedures.
Reviews engineering documents to ensure that the commissioning & startup requirements are accounted for in the design.
Drive alignment of Commissioning and Qualification requirements with Engineering and Construction teams to ensure all aspects are aligned with the program including adherence to engineering specifications, Receipt Verification, Third Party Inspection, Walkdown and Turnover Planning, Turnover Package Documentation, and Engineering Change Management
Ensures Amgen staff and Contingent workers on the Amgen Commissioning and Qualification Program are up to date with C&Q training requirements
Manages the execution of pre-commissioning, commissioning and start-up activities.
Prepares and provides commissioning progress reports
Coordinates assistance of the Vendor representatives, as required.
What we expect of you
Doctorate degree and 2 years of Engineering or Commissioning and Qualification Management experience
Masters degree and 6 years of Engineering or Commissioning and Qualification Management experience
Bachelors degree and 8 years of Engineering or Commissioning and Qualification Management experience
Associates degree and 10 years of Engineering or Commissioning and Qualification Management experience
High school diploma / GED and 12 years of Engineering or Commissioning and Qualification Management experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
We are all different, yet we all use our unique contributions to serve patients. The Engineering Projects professional we seek is a dynamic Sr Manager with the following preferred qualifications:
Bachelors Degree in Engineering or related technical field
10+ years of experience in engineering project execution and commissioning management
6+ years direct supervisory experience
6+years in the Pharmaceutical / Biotechnology industries
Extensive knowledge and proven experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects, specially Packaging and/or Automated Supply and Retrieval Systems (ASRS)
Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
Excellent communication skills
Strong collaborator, problem solver and solution oriented
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team- based environment.
Extremely organized and thinks strategically to support key business decisions
Ability to manage multiple tasks and effectively set priorities
What you can expect of us
As we work to develop treatments that take care of others, so we work to care of our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.